September 26, 2021


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Government committee recommends approval for Phase II-III trials of ‘Kovovax’

Government committee recommends approval for Phase II-III trials of 'Kovovax'

(Payal Banerjee)

New Delhi, Jul 27 (PTI) An expert committee of the Central Drugs Authority of India has asked the Serum Institute of India (SII) to conduct Phase II and III trials of the ‘Kovovax’ vaccine on children aged two to 17 years with certain conditions. The permission was recommended on Tuesday. Official sources gave this information.

The test will involve 920 children across 10 locations, including 460 children in each of the 12-17 and 2-11 age groups.

A source said, “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday considered the revised study protocol application submitted by SII and recommended the use of Kovovax on children aged two to 17 years. Recommended permission to the firm for Phase II and III trials.

The Pune-based pharmaceutical company had submitted a revised protocol for involving a pediatric team in the ongoing Kovovax Phase 2 and 3 controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the vaccine. .

In the revised application submitted last week, SII Director (Government and Regulatory Affairs) Prakash Kumar Singh and Director Dr. Prasad Kulkarni had said that globally, all adults aged 18 years and above are being vaccinated and its Afterwards people will be protected against COVID-19 and children will remain in the vulnerable group.

“There have been reports of serious illness including death in vulnerable children,” he said in the letter. It has also been expressed that fears have been expressed that the third wave of the pandemic may affect children in the country.” The SARS-CoV-2 virus can persist in circulation, putting everyone at risk of serious illness.

SII said that keeping all these factors in mind, several companies have started evaluating the safety and immunogenicity of COVID-19 vaccines in children.

Sources said that Union Health Minister Mansukh Mandaviya on Tuesday told the Bharatiya Janata Party (BJP) MPs that the Kovid vaccination for children is likely to start soon.

During the BJP Parliamentary Party meeting, Mandaviya said that the Kovid vaccination campaign is going on in full swing in the country.